Program Manager
New
N
NateraMolecular Diagnostics
Remote or On-Site in Boulder, CO, May be required to work across time zones as needed to support project schedules.Full-TimeMiddle
Salary103,800 - 129,700 USD per year
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Job Details
- Experience
- 3-5+ years
- Required Skills
- Jira
Requirements
- 3-5+ years of experience in program management or equivalent in biotechnology, diagnostics, clinical laboratory, or life sciences.
- Experience supporting product development in regulated environments (IVD, medical device, or similar).
- Background in NGS diagnostics, including assay and software components.
- Strong familiarity with design controls (ISO 13485) and software lifecycle processes (IEC 62304).
- Experience supporting regulatory submissions (e.g., IDE, 510(k), PMA, or equivalent) preferred.
- Ability to influence senior stakeholders and drive alignment in matrixed organizations.
- Excellent executive communication skills with ability to tailor messaging across technical and non-technical audiences.
- Proficiency with program management and collaboration tools (e.g., Smartsheets, JIRA, Office Timeline).
- PMP or equivalent certification preferred.
Responsibilities
- Drive end-to-end execution of product development programs, including planning, scheduling, resource coordination, and risk management.
- Support regulatory product development activities, ensuring alignment with quality systems like ISO 13485, IEC 62304, and FDA/CAP/CLIA requirements.
- Coordinate regulatory submission readiness, including support for IDEs, pre-submissions, and global filings.
- Lead cross-functional alignment across R&D, software, regulatory, quality, and clinical teams.
- Translate product strategy into actionable program roadmaps, including timelines, milestones, and interdependencies.
- Partner with Alliance Management to manage external biopharma and CDx partnerships.
- Communicate program status, risks, and trade-offs to senior leadership to enable data-driven decision-making.
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